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Ophthalmology. 2018 Nov;125(11):1700-1709. doi: 10.1016/j.ophtha.2018.08.002. Epub 2018 Aug 9.

Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study.

Author information

1
Devers Eye Institute, Portland, Oregon.
2
Stein Eye Institute, University of California, Los Angeles, Los Angeles, California.
3
Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio.
4
Jaeb Center for Health Research, Tampa, Florida.
5
Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
6
Dean Medical Center, Madison, Wisconsin.
7
The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
8
Michigan Cornea Consultants, PC, Southfield, Michigan.
9
SightLife, Seattle, Washington.
10
Northshore University Health System, Glenview, Illinois.
11
The Ohio State University Wexner Medical Center, Havener Eye Institute, Columbus, Ohio.
12
Mid Atlantic Cornea Consultants, Baltimore, Maryland.
13
Central Pennsylvania Eye Institute, Hershey, Pennsylvania.
14
Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
15
Woolfson Eye Institute, Atlanta, Georgia.
16
University of Michigan, Kellogg Eye Center, Ann Arbor, Michigan.
17
University of Illinois Chicago Eye and Ear Infirmary, Chicago, Illinois.
18
Verdier Eye Center, Grand Rapids, Michigan.
19
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
20
Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio. Electronic address: jonathan.lass@uhhospitals.org.

Abstract

PURPOSE:

To associate donor, recipient, and operative factors with graft success 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS).

DESIGN:

Cohort study within a multicenter, double-masked, randomized clinical trial.

PARTICIPANTS:

One thousand ninety individuals (1330 study eyes) with a median age of 70 years undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE; 6% of eyes).

METHODS:

Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (n = 675) or 8 to 14 days (n = 655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as regraft for any reason, a graft that failed to clear by 8 weeks after surgery, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was classified further as primary donor failure or early failure, in the absence or presence of operative complications, respectively. Proportional hazards and logistic regression models were used to estimate risk ratios (RR) and 99% confidence intervals (CIs) for graft failure.

MAIN OUTCOME MEASURES:

Graft success at 3 years.

RESULTS:

One thousand two hundred fifty-one of 1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR, 2.35; 99% CI, 1.03-5.33) and operative complications (RR, 4.21; 99% CI, 1.42-12.47) were associated with increased risk for primary or early failure. Preoperative diagnosis of PACE (RR, 3.59; 99% CI, 1.05-12.24) was associated with increased risk for late failure by 3 years after surgery compared with Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR, 1.19 per decade; 99% CI, 0.91-1.56 per decade), preoperative donor endothelial cell density (RR, 1.10 per 500 cells; 99% CI, 0.74-1.63 per 500 cells), graft diameter (RR, 1.22 per 1 mm; 99% CI, 0.39-3.76 per 1 mm), and injector use for graft insertion (RR, 0.92; 99% CI, 0.40-2.10).

CONCLUSIONS:

Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study.

PMID:
30098353
PMCID:
PMC6196643
[Available on 2019-11-01]
DOI:
10.1016/j.ophtha.2018.08.002
[Indexed for MEDLINE]

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